Antibiotic regimens for neonatal sepsis - a protocol for a systematic review with meta-analysis

Abstract Background Sepsis is a major cause of morbidity and mortality among neonates and infants. Antibiotics are a central part of the first line treatment for sepsis in neonatal intensive care units worldwide. However, the evidence on the clinical effects of the commonly used antibiotic regimens for sepsis in neonates remains scarce. This systematic review aims to assess the efficacy and harms of antibiotic regimens for neonatal sepsis. Methods Electronic searches will be conducted in MEDLINE, Embase, The Cochrane Library, CINAHL, ZETOC and clinical trial registries (clinicaltrials.gov and ISRCTN). We will include randomised controlled trials of different antibiotic regimens for sepsis of neonates and infants. Eligible interventions will be any antibiotic regimen. Two reviewers will independently screen, select, and extract data. The methodological quality of individual studies will be appraised following Cochrane methodology. Primary outcomes will be ‘all-cause mortality’ and ‘serious adverse events’. Secondary outcomes will be ‘need for respiratory support’, ‘need for circulatory support’, ‘neurodevelopmental impairment’, ototoxicity, nephrotoxicity and necrotizing enterocolitis. We plan to perform a meta-analysis with trial sequential analysis. Discussion This is the study protocol for a systematic review on the effects of different antibiotic regimens for neonatal sepsis. The results of this systematic review intent to adequately inform stakeholders or health care professionals in the field of neonatal sepsis, and to aid appropriate development of treatment guidelines. Systematic review registration PROSPERO reference number: CRD42019134300.

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Cannabinoids versus placebo or no intervention for pain: protocol for a systematic review with meta-analysis and trial sequential analysis

BMJ Open ◽

10.1136/bmjopen-2019-031574 ◽

2019 ◽

Vol 9 (10) ◽

pp. e031574 ◽

Cited By ~ 1

Author(s):

Jehad Ahmad Barakji ◽

Steven Kwasi Korang ◽

Joshua Feinberg ◽

Mathias Maagard ◽

Christian Gluud ◽

...

Keyword(s):

Systematic Review ◽

Sequential Analysis ◽

Meta Analysis ◽

Well Being ◽

Primary Data ◽

Current Evidence ◽

Cochrane Library ◽

Trial Sequential Analysis ◽

Clinical Effects ◽

Harmful Effects

IntroductionPain is a frequent clinical symptom with significant impact on the patient’s well-being. Therefore, adequate pain management is of utmost importance. While cannabinoids have become a more popular alternative to traditional types of pain medication among patients, the quality of evidence supporting the use of cannabinoids has been questioned. The beneficial and harmful effects of cannabinoids in patients with pain is unknown. Accordingly, we aim to assess the efﬁcacy, tolerability and safety of cannabinoids (herbal, plant-derived extracts and synthetic) compared with placebo or no intervention for any type of pain.Methods and analysesWe will conduct a systematic review of randomised clinical trials with meta-analysis and Trial Sequential Analysis to assess the beneficial and harmful effects of cannabinoids in any dose, formulation and duration. We will accept placebo or no treatment as control interventions. We will include participants with any type of pain (acute and chronic pain, cancer-related pain, headache, neuropathic pain or any other types of pain). We will systematically search The Cochrane Library, MEDLINE, Embase, Science Citation Index and BIOSIS for relevant literature. We will follow the recommendations by Cochrane and the Preferred Reporting Items for Systematic Review and Meta-Analysis statement. The risk of systematic errors (bias) and random errors (play of chance) will be assessed. The overall certainty of evidence will be evaluated using the Grading of Recommendations Assessment, Development and Evaluation approach.Ethics and disseminationEthical approval is not a requirement since no primary data will be collected. The findings of this systematic review will be submitted for peer-reviewed publication and disseminated in national and international conferences.DiscussionAlthough cannabinoids are now being used to manage different pain conditions, the evidence for the clinical effects are unclear. The present review will systematically assess the current evidence for the benefits and harms of cannabinoids to inform practice and future research.

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Effectiveness of Acupuncture in Relieving Chemotherapy-induced Leukopenia in Patients With Breast Cancer: A Systematic Review With A Meta-Analysis and Trial Sequential Analysis

Integrative Cancer Therapies ◽

10.1177/15347354211063884 ◽

2021 ◽

Vol 20 ◽

pp. 153473542110638

Author(s):

Ya Wen Shih ◽

Jui Yuan Su ◽

Yu Shan Kung ◽

Yu Huei Lin ◽

Duong Thi To Anh ◽

...

Keyword(s):

Breast Cancer ◽

Systematic Review ◽

Random Effects ◽

Sequential Analysis ◽

Meta Analysis ◽

White Blood Cells ◽

Cochrane Library ◽

Common Side Effect ◽

Trial Sequential Analysis ◽

Random Effects Model

Background: Breast cancer is one of the most common cancers and a major cause of death in women worldwide. Chemotherapy is mainly used to treat and control the progression of breast cancer. Leukopenia is the most common side effect of chemotherapy which may decrease immune function and further lead to serious fatal infections. The purpose of this study was to evaluate the effect of acupuncture on regulating hematopoietic function in chemotherapy-induced leukopenia among patients with breast cancer. Methods: PubMed, Embase, Cochrane Library, CINAHL Plus, Web of Science, and Chinese articles in the Airiti Library and China National Knowledge Infrastructure (CNKI) databases were searched to August 2021 for papers to include in a systematic review and meta-analysis. A random-effects model was applied. The effect size was calculated by Hedges’ g. Heterogeneity was determined using Cochran’s Q test. Moderator analyses were performed to examine potential sources of heterogeneity. A trial sequential analysis (TSA) was conducted to determine whether the current sample size was sufficient. Results: Ten randomized controlled trials involving 650 participants were eligible for inclusion. Analysis by the random-effects model showed a significant effect by acupuncture of ameliorating leukopenia during chemotherapy. Levels of white blood cells (WBCs) were increased (Hedges’ g = 0.70, P < .001, I2 = 34%), neutrophil counts (Hedges’ g = 0.80, P < .001, I2 = 0%) were significantly enhanced. Moreover, regardless of the manner through which acupuncture was applied, overall values of WBCs increased. Conclusions: The current meta-analysis supports acupuncture possibly ameliorating chemotherapy-induced leukopenia, as WBC and neutrophil values significantly increased after acupuncture in patients undergoing chemotherapy. Additionally, regardless of the type of acupuncture, values of WBCs increased. These findings are actionable and support both the clinical use of acupuncture to relieve chemotherapy-induced leukopenia and further research regarding the use of acupuncture in patients experiencing immunosuppression when undergoing chemotherapy. Trial Registration: PROSPERO-CRD42020215759.

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Clinical Effects of Mercury in Conservative Dentistry: A Systematic Review, Meta-Analysis, and Trial Sequential Analysis of Randomized Controlled Trials

International Journal of Dentistry ◽

10.1155/2020/8857238 ◽

2020 ◽

Vol 2020 ◽

pp. 1-12

Author(s):

Romeo Patini ◽

Gianrico Spagnuolo ◽

Federica Guglielmi ◽

Edoardo Staderini ◽

Michele Simeone ◽

...

Keyword(s):

Systematic Review ◽

Sequential Analysis ◽

Biological Fluids ◽

Meta Analysis ◽

Dental Amalgam ◽

Risk Of Bias ◽

Composite Resins ◽

Trial Sequential Analysis ◽

Controlled Trials ◽

Clinical Effects

Background and Purpose. Following the new directives of the European Union, which foresee the amalgam ban, the debate on its hypothetical toxicity has started again. So, the aim of this systematic review is to definitively evaluate the eventual effects of the exposure to Hg in adults and children with and without dental amalgam fillings measuring the Hg concentration in various biological fluids. Methods. A systematic literature search was conducted in four electronic databases (Ovid via PubMed, Web of Science, Scopus, and CENTRAL) including all available randomised controlled trials published in the last 15 years comparing the use of dental amalgam with composite resins in humans with a follow-up period of at least one year. The primary outcome was the Hg concentration in biological fluids (urine, hair, blood, and saliva) with the aim of assessing their reliability as biomarkers of Hg exposure. The risk of bias was assessed through the Cochrane Collaboration tool and the overall quality of evidence through the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system. The results of the meta-analysis were expressed using a random-effects model, and their power was assessed through the trial sequential analysis (TSA). Results. From the initial 2555 results, only 6 publications were included in the review: five were considered as having high risk of bias, whereas one as having moderate risk. Only two articles were eligible for quantitative analysis. The meta-analysis gathered data from 859 patients but was nevertheless not significant (p = 0.12). The TSA confirmed this evidence revealing that it was due to a lack of statistical power since the required information size (RIS) threshold is not reached. Conclusions. The existing evidence revealed that there are not enough data to support the hypothesis that restorations with dental amalgam can cause nephrotoxicity when compared with composite resins restorations.

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Acupuncture for breathlessness in advanced cancer: a protocol for systematic review and meta-analysis with trial sequential analysis

BMJ Open ◽

10.1136/bmjopen-2021-054917 ◽

2021 ◽

Vol 11 (11) ◽

pp. e054917

Author(s):

Zihan Yin ◽

Tao Xu ◽

Mingsheng Sun ◽

Ling Zhao ◽

Fanrong Liang

Keyword(s):

Systematic Review ◽

Advanced Cancer ◽

Sequential Analysis ◽

Meta Analysis ◽

Biomedical Literature ◽

Cochrane Library ◽

Trial Sequential Analysis ◽

Controlled Trials ◽

Cochrane Central Register

IntroductionBreathlessness in advanced cancer, a frequent multicomponent and debilitating disorder, severely reduces function and quality of patients’ life. Multiple studies have shown that non-pharmacological therapies can effectively palliate breathlessness in advanced cancer. However, no systematic review has investigated the application of acupuncture, as a non-pharmacological treatment, for breathlessness in advanced cancer. A systematic review will be conducted to summarise evidence supporting the efficacy and safety of acupuncture as a therapeutic option for breathlessness in advanced cancer based on existing randomised controlled trials (RCTs).MethodsRCTs will be retrieved from nine scientific databases, including the MEDLINE via PubMed, Web of Science via the Web of Knowledge, Embase via Ovid, the Cochrane Central Register of Controlled Trials via the Cochrane Library, and Allied and Complementary Medicine Database via EBSCO, China National Knowledge Infrastructure, Wanfang Database, VIP Database, Chinese Biomedical Literature Database; three clinical registry platforms, including the WHO International Clinical Trials Registry Platform, NIH Clinical trials.gov and Chinese Clinical Trial Registry, as well as from other sources. Studies published since inception of these databases to 1 August 2021 will be retrieved. Search terms will include breathlessness, cancer, acupuncture and RCT. Two investigators will independently select and extract data from RCTs and assess the risk of bias. The primary outcome, which is alleviation of breathlessness, will be assessed. Meta-analysis will be performed using RevMan V.5.4 and STATA V.15.0. The TSA 0.9.5.10 β software will be used to conduct trial sequential analysis. Finally, the quality of evidence from RCTs will be assessed using the Grading of Recommendations Assessment, Development and Evaluation System tool.Ethics and disseminationResults will be disseminated through peer-reviewed journals or conference reports. Since this study involves acquisition of secondary data, ethical approval requirements will be waived.PROSPERO registration numberCRD42021240085.

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